ENGLEWOOD, CO., June 16, 2015 /PRNewswire/ — Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today provided shareholders information on the formation and recent activities of Aytu BioScience, Inc. (OTCMKTS: RSWND; http://aytubio.com/), a specialty healthcare company focused on developing treatments for urological and related conditions. Aytu was founded on therapeutic and diagnostic assets previously owned by Ampio Pharmaceuticals.
Ampio CEO Michael Macaluso explained, “Ampio owns 81.5 percent of Aytu Bioscience, an emerging specialty healthcare company with an experienced executive management team. We believe Aytu will provide Ampio shareholders a better return, allowing Ampio to concentrate on the development of near-term assets, AmpionTM and OptinaTM – two investigational compounds being tested for the treatment of prevalent inflammatory conditions for which there are limited treatment options.”
On May 20, 2015 Aytu entered into an agreement with Jazz Pharmaceuticals (NASDAQ: JAZZ) to acquire ProstaScint®, an imaging agent used to detect the extent and spread of prostate cancer that is marketed in the U.S. ProstaScint’s established brand and revenue will enable Aytu to expand its footprint in urology and help fund the clinical development of its pipeline products, Zertane™ and the RedoxSYS® System.
Josh Disbrow and Jarrett Disbrow, Aytu’s CEO and COO respectively, have nearly 40 years of combined experience in leadership positions at specialty life science companies. Prior to becoming the executive management of Aytu BioScience, Josh and Jarrett were the founding management team of Arbor Pharmaceuticals, a specialty pharmaceutical company incorporated in 2006. From inception until their exit from Arbor, they succeeded in raising capital, rapid expansion of the company’s product line growth, and build out of a commercial infrastructure to more than 200 people and annual net revenues in excess of $200 million.
Zertane™, the company’s most advanced therapeutic, is an oral drug in late stage development as a proprietary treatment for premature ejaculation (PE). PE is a condition that has a major impact on the quality of life for millions of men and their sexual partners. Zertane™ has successfully completed two Phase 3 European Trials and will begin Phase 3 studies in the USA shortly under FDA IND. Zertane™ has the potential to be the first oral therapeutic approved in the U.S. for the treatment of PE. The company has distribution partners in South Korea, Brazil, Canada, South Africa and Latin America.
ProstaScint® is a radio-labeled monoclonal antibody that targets Prostate Specific Membrane Antigen (PSMA), a protein uniquely expressed by prostate tissue. As an imaging agent, ProstaScint® can identify prostate cancer. ProstaScint® is approved in the U.S. and a field force is being engaged to expand awareness and support sales.
RedoxSYS® System, measures (1) Static Oxidation Reduction Potential (sORP) from a single drop of blood, which provides a valuable “snapshot” of current redox balance that correlates with illness, injury severity and mortality. A higher sORP reading is indicative of oxidative stress and (2) Capacity ORP (cORP) a measurement of the amount of antioxidant reserves that correlates with the patient’s ability to respond to illness or injury. The RedoxSYS® oxidation-reduction potential platform is currently marketed for research use. Through the company’s extensive network of research partnerships, the RedoxSYS® platform has demonstrated broad clinical application potential. Studies are underway in the area of male infertility. Male infertility is a prevalent and underserved condition and oxidative stress is widely implicated in its pathophysiology.
About Aytu BioScience
Aytu BioScience is a specialty healthcare company focused on developing treatments for urological and related conditions. The company is currently completing Phase 3 clinical development for its lead therapeutic candidate Zertane™, an orally disintegrating tablet (ODT) formulated specifically for the on-demand treatment of premature ejaculation (PE). The company’s therapeutic pipeline is supported in part by its first-in-class RedoxSYS® System, which provides the only complete assessment of patients’ redox status and enables identification of a broad variety of disorders where redox is implicated. Initial studies are underway utilizing the RedoxSYS system in male fertility. It also recently acquired and expects to commercialize FDA-approved ProstaScint® (capromab pendetide), a radio-labeled monoclonal antibody, that targets Prostate Specific Membrane Antigen (PSMA), a protein uniquely expressed by prostate tissue. The company’s strategy is to develop its core therapeutic and diagnostic assets while building an innovative pipeline of established marketed products and late-stage development assets.
About Ampio Pharmaceuticals
Ampio Pharmaceuticals, Inc. is a clinical trial stage biopharmaceutical company primarily focused on the development of therapies to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio is developing compounds that decrease inflammation by (i) inhibiting specific pro-inflammatory compounds by affecting specific pathways at the protein expression and at the transcription level; (ii) activating specific phosphatase or depletion of the available phosphate needed for the inflammation process; and (iii) decreasing vascular permeability.
Forward Looking Statements
Ampio’s statements in this press release that are not historical fact and that relate to future plans or events are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by use of words such as “plan,” “continue”, “present,” “could,” “may,” “will,” and similar expressions. These forward-looking statements include statements regarding Ampio’s plans with respect to the AmpionTM and its affects and the ability of Aytu to provide a return to investors, which are subject to the risks associated with clinical trials, regulatory approvals, and changes in business conditions and similar events. These risks include the uncertainty of the regulatory response to the sufficiency of trial data and trial design, that regulatory approval may not be obtained or delayed, and the risks and uncertainties detailed from time to time in Ampio’s filings with the Securities and Exchange Commission, including without limitation, under Ampio’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.
Gregory A. Gould
Ampio Pharmaceuticals, Inc.
Direct: (720) 437-6513
Direct: (415) 318-4262
Additional Investor and Media Contacts
Tiberend Strategic Advisors, Inc.
Joshua Drumm, Ph.D.
Direct: (212) 375-2664
Direct: (646) 604-5150